Sterilizable flexible pouch package

ABSTRACT

A high temperature steam-sterilizable flexible pouch package includes a non-woven barrier web, a perforated plastic intermediate web, and an imperforate plastic upper web. Line heat seals bonding the webs form a cavity into which high temperature sterilizing steam may enter after passing through the barrier and intermediate webs. The line heat seal bonding the upper and intermediate webs is of the delamination failure type. An access opening is provided for insertion of an object to be sterilized into the cavity after which the access opening is sealed, enclosing the object in the cavity. After high temperature steam sterilizing, the package is opened by peeling apart the upper web from the intermediate web which causes a delamination failure of the line heat seal. Preferred materials enable vacuum cycle steam sterilization at a temperature of at least 270° F.

This application is a division of application Ser. No. 08/576,556 filedDec. 21, 1995, now U.S. Pat. No. 5,653,090, which was acontinuation-in-part of application Ser. No. 08/361,321 filed Dec. 21,1994, now U.S. Pat. No. 5,590,777.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a steam-sterilizable flexible pouch package,to a method of using the pouch, and to apparatus which facilitates useof the pouch. More particularly, the invention relates to such poucheswhich are steam-sterilizable and preferably sterilized in vacuum cyclesterilizers with steam at high temperatures, typically at least about270° F. and which are reliably openable, by peeling, after suchsterilization. Still more particularly, the invention relates to suchpackages which are sufficiently large and robust to permit suchsterilization of heavy objects, such as a tray bearing medical devicesor instruments.

2. Description of Related Art

Various medical instruments and supplies are subjected, prior to use inhospitals, to sterilization treatments such as, for example,sterilization with a sterilizing fluid such as steam, ethylene oxidegas, or hydrogen peroxide plasma, radiation sterilization, anddry-heating sterilization. Ordinarily, the first step in sterilizationis to package or wrap the unsterile device before exposing it to asterilant. Generally, packages are used for sterilization of small,lightweight objects and wrapping is used for sterilization of heavyobjects, particularly metal trays in which one or more objects are held.Such trays are usually made of stainless steel and typically weigh from5 to 16 pounds, and often up to 30 pounds, when loaded.

In all sterilization treatments, there is a general requirement toobserve a sterile technique. In the context of packaging or wrapping, itis particularly important that sterile technique be practiced duringunwrapping or during opening of a package. For example, steriletechnique does not allow a hand or object to contact a sterile item. Itis important, therefore, that any flexible wrapping or packagingmaterial have good drapeability such that it will readily fall away froma sterilized item as the item is unwrapped or as a sterilized package isopened.

A current practice of wrapping a tray for steam sterilization employs adouble-layered muslin cloth, commonly known as CSR wrap, that is securedaround an unsterile medical device by taping. The wrap permits the steamto penetrate into and out of the interior of the cloth wrap, but acts asa barrier to bacteria and other organisms after sterilization. Normally,a dust cover is also employed in the post-sterilization phase. CSR clothwrap, however, is prone to fluid strike-through and exhibits tearingwith extended use. In addition, steam sterilization methods employingcloth wrap are normally practiced by first unwrapping the sterilizedtray, followed by moving the unwrapped tray to an area where the traycontents will be used. Sterile technique requires careful and preciseprocedures. Accordingly, cloth wrap practice is time consuming andexpensive.

An alternative practice replaces muslin wrap with a disposable non-wovenCSR wrap that is applied in the same manner, i.e., double-layering ofwrap secured by taping and with the use of a dust cover. More recently,a single-layer disposable non-woven CSR wrap has been proposed. Althoughnon-woven CSR wraps offer both improved fluid resistance and improvedbacterial barrier migration over their cloth counterparts, sterilizationpractices that use these non-woven materials are still labor intensiveand costly.

Steel or plastic self-contained reusable trays fitted with an outerhousing that has a replaceable filter have also been employed assterilization containers. While the steel tray system offers excellentsterility maintenance, it is not an attractive practice for manyhospitals because the containers are extremely expensive. Plastic trays,unlike the steel trays, allow for visual inspection and identificationof contents by employing a transparent plastic. Although to a lesserdegree than the steel counterpart, plastic self-contained sterilizationtrays are also expensive. Moreover, sterilization trays haveconsiderable mass which gives rise to a problem of sterilant condensatewhich arises with this method of sterilization.

Sterilization pouches and bags comprised of paper and plastic webs havefound wide applications in hospitals. Plastic webs may afford easyidentification of contents through a transparent plastic web. However,as mentioned above, these applications have been limited tosterilization of small or lightweight objects that are easily packaged.

Kraft paper, both coated and uncoated, is used in such packages for bothsteam and gas sterilization but is not well suited for heavy objects.Moreover, opening a sealed paper package gives rise to the generation ofloose paper fibers, which is undesirable in an operating room or otherarea where dust is desirably kept to a minimum.

Non-woven materials have been substituted for paper in such packages.For example, sheets of spun-bonded polyolefin such as "Tyvek" are widelyused in packages for gas sterilization. "Tyvek" offers greaterdrapeability and reduced fluid strike-through as compared to Kraftpaper. However, Tyvek will not withstand high temperature steamautoclaving, and is not employed as an alternative to CSR wrap in hightemperature steam sterilization.

It is obviously important that a sterilizable package be reliablysealed, and that it remain sealed after sterilization such that itssterilized contents remain sterilized for the required time, generallyfor at least 30 days in the case of hospital instruments. It is alsoimportant, however, that the sealed sterilized package is reliablyopened without requiring excessive force and without the risk ofgenerating fiber "dust". Peelable heat seals or "peel seals" betweenopposed plastic webs have been proposed as being suitable for both ofthese important properties. For example, Sellers, U.S. Pat. No.3,410,395, discloses a package which comprises a laminar sheet materialfolded onto itself or assembled with another separately formed sheet orpanel and heat sealed to form a pouch. The laminar sheet materialcomprises a perforated heat sealable film, preferably polyethylene,which is laminated with and bonded to a paper sheet. Steam can penetrateboth the paper layer and the perforated film layer to enter the pouch.The heat seal between the facing panels or sheets is said to be peelableand the package is said to be able to withstand steam sterilization andable to be peeled open by the application of a moderate opposing pullingforce.

At the present time, most steam sterilization of medical instruments andthe like is carried out in hospitals and medical facilities withsaturated steam. Sterilization, effected in a vacuum cycle autoclave,has three phases: preconditioning; exposure; and drying. In thepreconditioning phase, after placing the object(s) to be sterilized inan autoclave, saturated steam can be introduced at elevated pressure,typically at least 10-15 psig, followed by evacuating the autoclave toan absolute pressure of about 10-20 inches of mercury. The autoclave isalso heated by a steam jacket, with jacket steam typically at atemperature of about 250-275° F. These steam/vacuum conditioning pulsesare usually repeated at least once and often three or four times, andthe total preconditioning time is at least 4-5 minutes and up to 30minutes or longer. In the next, exposure, phase saturated steam isintroduced and pressure raised and to mention saturated steam at atarget temperature and for a predetermined period of time. In gravitysteam sterilization, a typical target temperature of about 250° F. istypically maintained for up to 20 minutes or more. Most steamsterilization of packaged or wrapped medical instruments is carried outin hospitals and medical facilities in vacuum cycles with saturatedsteam at much higher target temperatures, usually at least about 270°F., and with an exposure time of usually at least three minutes. In thesubsequent drying phase, the pressure is reduced and autoclave is againevacuated, typically to an absolute pressure of about 10-20 inches ofmercury or less, with continued heating via the heated jacket. Jackettemperature is typically 250-275° F. The drying phase typically lastsfor at least about 5-10 minutes and may be as long as sixty minutes ormore. Autoclave equipment for effecting such steam sterilization iswidely available commercially and includes complete automation forcarrying out the process under predetermined conditions. The presentinvention has particular applicability to flexible film packages whichare suitable for autoclave sterilization at high steam exposuretemperatures of at least 270° F. These conditions are referred tohereinafter as high temperature vacuum cycle steam sterilizationconditions. The packages disclosed by Sellers are incapable ofundergoing sterilization at these conditions.

Wilkes, U.S. Pat. No. 4,367,816 discloses a package which is said to begas sterilizable, and no mention is made of steam sterilization. Thispackage comprises a low density polyethylene sheet which is heat sealedto a laminar tear strip made up of a gas-permeable paper sheet bonded toa perforated plastic film, the latter film being a sheet of high densitypolyethylene coated on both sides with a thin layer of a blend ofethylene vinyl acetate and low density polyethylene. The latter layer isheat sealed to the low density polyethylene sheet to form a peelableheat seal. Again, however, the materials will fail if the package issubjected to conventional high temperature steam sterilizationconditions. A chevron type package is illustrated in FIG. 7.

Various types of line heat seals which join heat-sealable plastic websare known in the art. Several of these line heat seals are referred toas "peelable" seals or "peel" seals. A peelable line heat seal is a lineheat seal which is openable along the line heat seal by pulling apartheat sealed webs. At least three distinct types of peelable line heatseals are known. In a "true" peel seal, the heat sealed webs separate attheir heat sealed interface, with little or no transfer of material fromone web to the other. In a "cohesive failure" peel seal, as the heatsealed webs are peeled apart, there is a cohesive failure of only one ofthe heat sealed webs. The failing heat sealed web tears in a plane whichis generally parallel with the plane of the heat seal, Some of thecohesively failed heat sealed web transfers to the web to which it isheat sealed, and some remains behind with the failing heat sealed web.In this type of seal, the strength of the failing heat sealed web isweaker than the heat seal itself. A "delamination failure" or "adhesivefailure" peelable heat seal is similar to a cohesive failure seal inthat a portion of a failing heat sealed web transfers to the non-failingweb. In a delamination failure peel seal, however, the failed web is alamination, and failure occurs in a predictable location, namely betweenlaminae. In the simplest case, the failing web is a two layerlamination, one layer of which is a heat seal layer which is permanentlyheat sealed along a permanent line heat seal to the other web. When theheat sealed webs are pulled apart, the failing web readily delaminatesin the region of the permanent line heat seal because the permanent lineheat seal which bonds the two webs is stronger than the bonding strengthbetween the layers of the failing web. Pulling the webs apart alsocauses the failing layer to tear at locations just outside and justinside the line heat seal because the bonding strength between thelayers of the failing web is stronger than the tear strength of the heatseal layer of the failing web. Thus, the portion of the heat seal layerof the failing web, in the region of the line heat seal, clearlyseparates by delamination and tearing in a predictable fashion from thelayer to which it was laminated, and this separated portion of thefailing heat seal layer is transferred to the non-failing web. Thus,failure is generally in a plane which is parallel to the plane of thepermanent line heat seal, and there is a transfer of the failed heatsealed layer, in the region of the permanent line heat seal, to the webwhich did not fail. However, in a delamination failure peel seal,failure proceeds predictably at the interface of the failing laminationand in the region of the permanent line seal.

The present invention relates to sterilizable pouch packages utilizing adelamination failure type of peelable line heat seal.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a flexible sterilizablepouch package which is steam-sterilizable and which is reliably sealedby a delamination failure peelable line heat seal and reliably openablealong the peelable seal after sterilization.

It is a further object of the invention to provide such packages whichare reliably openable after high temperature steam sterilization.

It is a further object to provide such packages which, when sealed, aresufficiently large and robust to permit steam sterilization of heavyobjects, such as large trays loaded with medical devices andinstruments, and which may be reliably opened by pulling apart apeelable line seal without undue force.

It is a further object to provide such packages which, when sealed, arecapable of being sterilized under high temperature vacuum cycle steamsterilization conditions including a phase of exposure to steam at atemperature of at least about 270° F. for at least three minutes, andwhich, after such steam sterilization, have a shelf life of at least 30days.

It is a further object of the invention to provide such packages whichpermit viewing of the package contents through the packaging material.

It is a further object to provide a method of high temperature steamsterilization of a sealed pouch in accordance with the invention and itis a further object to provide apparatus for facilitating the loading ofobjects into a sterilization pouch.

A flexible, steam-sterilizable pouch package according to the inventioncomprises:

a flexible, steam-permeable non-woven lower barrier web;

a flexible impermeable plastic upper web; and

a flexible, plastic intermediate web having an interior steam-permeableregion;

said intermediate web being bonded to said upper web by a firstpermanent line heat seal located peripherally outside saidsteam-permeable region, said first permanent line heat seal defininglimits of a cavity between said upper web and said intermediate web forreceiving an object to be sterilized, said first permanent line heatseal extending less than fully peripherally around said permeable regionwhereby a heat seal-free region of first permanent line heat sealprovides an access opening for inserting an item to be sterilized intosaid cavity;

said intermediate web being bonded to said barrier web by a secondpermanent line heat seal peripherally outside said steam-permeableregion of said intermediate web, said second permanent line heat sealbeing located such that, when the pouch is fully sealed, steam canpenetrate into said cavity only by passing first through said barrierweb and thereafter through said permeable region of said intermediateweb;

one of said intermediate and upper webs being a multi-layer web having afirst heat sealable layer and a core layer bonded thereto, and the otherof said intermediate and upper webs being heat sealable to the heatsealable layer of said multi-layer web and being heat sealed thereto bysaid first permanent line heat seal;

after high temperature steam sterilization of the package at atemperature of at least 270° F. the bond strength of said firstpermanent line heat seal being stronger than the bond strength betweensaid first heat sealable layer and said core layer of said intermediateweb, and the bond strength between said first heat sealable layer andsaid core layer of said multi-layer web being greater than the strengthof said first heat sealable layer of said multi-layer web, whereby aftersuch high temperature steam sterilization, a delamination failure peelseal is present between said intermediate and upper webs in the regionof said first permanent line heat seal.

A method of sterilizing an object according to the invention comprises:

(a) providing a flexible steam-sterilizable pouch according to theinvention;

(b) placing an object to be sterilized in the cavity of the pouch;

(c) sealing the pouch such that the object to be sterilized is sealed insaid cavity and such that steam can penetrate into said cavity only byfirst passing through the lower web and then through the perforatedregion of the intermediate web; and

(d) sterilizing the sealed pouch with steam at a temperature of at least270° F.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic plan view of a first embodiment of a pouchaccording to the invention;

FIG. 2 is a diagrammatic, enlarged, cross sectional view along line 2--2of FIG. 1;

FIG. 3 is a diagrammatic, enlarged, cross sectional view along line 3--3of FIG. 1;

FIG. 3A is a diagrammatic, enlarged, cross sectional view of analternative embodiment of a pouch according to the invention;

FIGS. 4-6 are diagrammatic cross sectional views showing, sequentially,the peeling open of a delamination failure peel seal of the pouch ofFIGS. 1-3;

FIG. 7 is a diagrammatic cross sectional view of a portion of analternative form of a pouch according to the invention;

FIG. 8 is a diagrammatic plan view of a second embodiment of a pouchaccording to the invention;

FIG. 9 is a diagrammatic plan view of the pouch of FIG. 8 with anadhesive strip attached thereto;

FIG. 10 is an enlarged, diagrammatic cross sectional view along the line10--10 of FIG. 9;

FIG. 11 is an enlarged, diagrammatic cross sectional view similar toFIG. 10, but showing the pouch after folding an end thereof;

FIG. 12 is a diagrammatic perspective view of apparatus for facilitatingthe insertion of an object to be sterilized into a pouch according tothe invention;

FIG. 13 is a diagrammatic side elevation view of the apparatus of FIG.12; and

FIG. 14 is a diagrammatic plan view of a third embodiment of a pouchaccording to the invention.

DEFINITIONS

The expression "delamination failure peel seal" as used herein means apeelable seal which opens as described hereinafter in connection withFIGS. 4-7.

The expression "permanent line heat seal" means a fusion or weld heatseal bonding two webs. The seal extends along a line and has a bondingstrength that is greater than either of the bonded webs. An attempt toseparate the bonded webs along the seal will result in destruction of atleast one of the webs.

The expression "laminated" refers a multi-layer structure in whichadjacent layers are bonded over essentially their entire adjacentsurfaces, and is used broadly to encompass coextrusions, truelaminations of pre-formed sheets bonded to one another either with orwithout adhesives, and coated layers.

A "barrier" web is a web that is sufficiently porous to steam to permitpassage of a steam sterilant for sterilization, and which is aneffective barrier against the passage of bacteria.

DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to FIGS. 1-3, a sterilizable pouch 10 in accordance withthe invention comprises a steam-permeable non-woven lower web 11, aplastic intermediate tri-layer web 12 and a plastic two-layer upper web13. While the term "pouch" is used herein, it will be understood thatsuch pouches are also referred to as bags, receptacles, and the like.Lower web 11 is bonded to intermediate web 12 by a fiber-tearingpermanent hermetic line heat seal 14. Intermediate web 12 is bonded toupper web 13 by a permanent hermetic line heat seal 15. Both heat sealsare provided in regions A, B and C (FIG. 1) of the webs. The terms"lower" and "upper" are used herein in the sense of the drawings and inthe sense in which the pouch is normally oriented in use. It is quitepossible to use the pouch with what is referred to herein as the "upperweb" lowermost. The upper and lower webs are, however, distinct in thatthe upper web is a steam-impermeable plastic web which is preferablytransparent and forms with the plastic intermediate web a cavity forholding an object to be sterilized. The lower web, on the other hand, issteam-permeable and may be opaque.

Lower web 11 may be any flexible steam-permeable barrier web whichprovides an effective barrier against the migration of micro-organisms,particularly bacteria, and which is capable of forming a fiber tearingpermanent line heat seal with the intermediate web, the web and the heatseal both preferably being capable of withstanding high sterilizationtemperatures such as steam sterilization at a temperature of at least270° F. Lower web 11 is preferably more drapeable than Kraft paper.

Suitable non-woven material for lower web 11 includes conventionalnon-woven materials used in the medical field. Paper and some plasticproducts, such as spun bonded polyolefin or polyester products, aresuitable. For high temperature vacuum cycle steam sterilization at 270°F., a suitable material is a non-woven blend of spunlaced polyester andcellulosic material sold under the trademark "Sontara", Other usefulnon-woven Sontara products are made up entirely of non-woven polyesteror non-woven polyester blended with rayon. A particularly preferredhigh-temperature material is a drapeable trilaminate polypropylenebarrier fabric such as "Securon" (Fiberweb Group) which has an innermelt-blown polypropylene core layer between outer spun-bondedpolypropylene layers.

One of the principal advantages of the invention is in the ability touse the pouch for sterilizing heavy objects weighing up to about thirtypounds. Lower web 11 together with intermediate web 12 will support theweight of an object in the pouch. If web 12 is sufficiently strong tobear the entire load, the load-bearing strength of web 11 is not ofparticular concern. Quite the opposite is true, of course, if web 12 haslittle load bearing strength. The weight of web 11 needed to achieve thedesired strength will, of course, depend on the strength-to-weightcharacteristics of the web. In view of the foregoing, it will beunderstood that when considering load-bearing properties only, theweight (i.e., the thickness) of web 11 can vary quite widely. Ingeneral, it is preferred that webs 11 and 12 together are sufficientlystrong to support the full weight of any object for which a particularpouch is designed to accommodate. Since bottom layer 11 is an outerlayer, it is preferably abrasion and tear resistant and has the generalqualities required for maintenance of sterility. Web 13 is preferablyalso sufficiently strong to bear the entire load of objects in thepouch.

Web 11 should be sufficiently permeable to steam to permit sterilizationto be accomplished under conventional high temperature conditions, suchas with saturated steam at about 270° F. for a three minute exposurephase. Steam sterilization under these conditions is indicated by astandard test in which test microorganism are killed to a suitablespecified level such as the 10⁻⁶ level. Conventional and widelyavailable web materials of the type mentioned above have more thanadequate porosity.

Barrier web 11 must also constitute an adequate barrier against themigration of bacteria. Adequacy in this respect is measured by measuringshelf-life of a sterilized package. Adequate barrier properties areindicated when a sterilized objects sealed package stored at roomtemperature under ambient conditions, remains sterile after at least 30days. It will be understood that this property may also be involved indetermining the required weight of web 11. Thus, where strengthconsiderations may allow a very light weight web, microbial barrierproperties may require a heavier weight. Securon barrier fabric having aweight of from 1 to 4 ounces per square yard is preferable for hightemperature steam sterilization. Conventional and widely available websof the materials mentioned above are readily available in weights whichgive clearly adequate strength and microbial barrier properties.

Microbial barrier properties may be enhanced by incorporating one ormore anti-microbial agents such as a bactericide into the barrier web.For example, web 11 may be impregnated with a solution of a quaternaryammonium bactericide and then dried to incorporate the bactericide inthe web. Similarly, web 11 may be treated to enhance its waterrepellency. For example, the web may be treated with a conventionalpolysiloxane water repellant.

For load bearing purposes, for tear resistance and generally forincreased robustness, the weight of barrier web 11 may be appropriatelyheavy. It is preferred, however, to employ two or more barrier webs forthis purpose of relatively lighter weight such as webs 11 and 11aillustrated in FIG. 3A. Web 11a is preferably secured to web 11 by apermanent line heat seal 14' which is directly in alignment below heatseal 14. In that event, heat seal 14' is preferably formed at the sametime that heat seal 14 is formed. Web 11a, however, can be joined to web11 in any convenient way such as by an adhesive line seal in which casethe seal line is preferably directly in alignment below heat seal 14. Inany case, however, it is not necessary that webs 11 and 11a are joinedby a line seal. It is only necessary that they are bonded sufficientlyto remain in place forming the bottom web of the package, and that thebottom web is sufficiently steam-permeable and forms a barrier tobacteria in the same manner as where a single web 11 is employed. In apreferred method of making the package, webs 11 and 11a are heat sealedto each other with the formation of the other heat seals of the pouch.That is, all of the heat seals of the pouch, including heat seal 14',are made simultaneously. High temperature steam sterilization,particularly of heavy trays, sometimes causes "branding" or cuttingthrough of web 11. Provision of at least one further barrier web reducesthis adverse result.

Intermediate web 12 is a flexible heat sealable plastic web having abottom layer 121, a core layer 122, and a top layer 123. The terms "top"and "bottom" are again used in a sense of the normal orientation of thepouch in use, that is, with the pouch disposed generally horizontallywith upper web 13 uppermost as shown in FIGS. 2 and 3. Top layer 123 ofweb 12 is a plastic layer which forms a hermetic permanent line heatseal 15 with upper web 13, and is preferably polypropylene or apolypropylene copolymer such as a propylene-ethylene copolymer, orblends thereof. Preferred propylene-ethylene copolymers contain ethylenein the range of up to 6%, preferably 1-5%. Bottom layer 121 of web 12 isa plastic which forms a hermetic permanent line heat seal 14 withbarrier web 11. Suitable plastic materials include polypropylene, orpropylene copolymers, or blends of polypropylene and a polymer such aspolyisobutylene-modified high density polyethylene referred to herein as"RMHDPE". A blend of polypropylene with from 20-80% by weight andpreferably 30-70% by weight RMHDPE based on the weight of the blend, ispreferred. A preferred RMHDPE contains from 5 to 60%, more preferably20-40% and most preferably 20 or 25-35% by weight of polyisobutylene(PIB) based on the weight of the RMHDPE.

Core layer 122 is a polyisobutylene-modified high density polyethylene(RMHDPE) preferably containing from 5 to 60% by weight of PIB and morepreferably containing from 20-40% PIB, and most preferably containing 20or 25-35% PIB, based on the weight of the RMHDPE, or a blend thereofwith up to about 75% by weight of polypropylene, based on the weight ofthe blend. Inorganic additives such as calcium carbonate, mica, silica,talc or barium sulphate may be added to one or more of the layers of theintermediate web.

Delamination failure of the peelable line heat seal of the pouch packageof FIGS. 1-3 is shown in FIGS. 4-6. The peelable line heat seal depictedin FIGS. 4-6 is between upper web 13 and intermediate web 12 in lineseal region "B" of FIG. 1. This peelable seal is opened by graspingflange area 131 of upper web 13 with one hand while simultaneouslygrasping flange areas 111 and 125 of webs 11 and 12 with the other hand,and pulling apart. Permanent line seal 15 is stronger than the bondingstrength between heat seal layer 123 and core layer 122 of intermediateweb 12 which in turn is stronger than the strength of heat seal layer123. Accordingly, pulling apart web 13 from webs 11 and 12 causes heatseal layer 123 to delaminate in an area 1001 in the region of heat seal15 and to tear in areas 1002 and 1003 just outside and inside of theregion of line heat seal 15 as shown in FIG. 5. As shown in FIG. 6, aportion 123A of heat seal layer is separated from core layer 122 in theregion of heat seal 15, and is transferred to upper web 13. The gap 123Bin web 12 and portion 123A adhered to web 13 provide visual indicationof the proper functioning of the delamination failure heat seal.Delamination failure of the peel seal in the manner just described isensured by the relative strengths of the materials and bonds making upthe seal.

In an alternative embodiment, delamination of the peelable seal occursin the upper web. This is illustrated in FIG. 7 which is a diagrammaticcross sectional view corresponding to FIG. 6 except that in thisembodiment, delamination occurs in the upper web. The pouch is generallysimilar to the pouch of FIGS. 1-3 and like portions are designated bylike numerals. The pouch illustrated in FIG. 7 includes a lower web 11,an intermediate web 22, and an upper web 23, with cavity 16 between theintermediate and upper webs. Permanent line heat seals 14 and 15 areprovided as described above. In this embodiment, however, upper web 23is a three-layer web with its heat seal layer 231 and core layer 232corresponding, respectively, to heat seal layer 123 and core layer 122of the pouch of FIGS. 1-3. Permanent line heat seal 15 is formed betweenlayers 231 and 222. Intermediate web 22 is heat sealable, by permanentline heat seal 14, to barrier web 11 and may include a heat seal layer221 for this purpose. Intermediate web 22 may also include a core layerfor strength or for purposes of promoting adhesion between layers 221and 222. Intermediate web 22 may also be a mono-layer, provided that itis heat sealable via permanent line heat seals 14 and 15, to the upperand lower webs.

Accordingly, as the pouch of this embodiment is pulled open as describedabove in connection with FIGS. 4-6, delamination failure involvestearing of heat seal layer 231 at 2001 and 2002 and delamination inregion 2003, thus creating access to cavity 16.

It is important that steam sterilization does not adversely effect thestrength of the various heat seals, and the relative strengths thereofwhich result in predictable delamination failure of the peel sealwithout requiring undue force. In other words, it is important that theseals have these characteristics after the package has been subjected tosteam sterilization. It has been found that high temperature steamsterilization actually enables predictable peelability of the presentdelamination failure peel seal.

When the package is subjected to sterilization at lower temperatures,such as temperatures normally employed in gas sterilization inhospitals, it has been found that the package, particularly the top web,fails when one attempts to open the package. The top web typicallyfractures. After steam sterilization, however, the peel seals functionproperly. The high steam sterilization temperature has been found toactivate or enable the seals to be predictably peelable.

Referring again to FIGS. 1-3, upper web 13 is superposed directly abovetop heat seal layer 123 of web 12 and lower web 11 is positioneddirectly below bottom heat seal layer 121 of web 12. The three layers(121, 122 and 123) of web 12 are bonded together at least at marginalregions of the layers and are preferably at least substantiallycoextensive and bonded together across their entire mutually adjacentsurfaces. Bonding can be effected by an adhesive seal, by a heat seal,by coextrusion, by lamination of discrete films, etc. Bonding betweencore layer 122 and bottom layer 121 may be effected by means of one ormore tie layers interposed between the layers. Such tie layers may bebonded to the respective layers in any of the ways just mentioned.However, it is critical in this embodiment of the invention that thebonding of the upper web layer 13 to the top layer 123 of intermediateweb 12 forms a reliable delamination failure seal peel with delaminationoccurring only in the area of the line heat seal, and only between heatseal layer 123 and core layer 122 of web 12.

The relative permanent heat seal strengths, the strength of the failingheat seal layer, and the strength of the bond between the failinglaminae can be achieved by conventional means known in the art such asby selection of the plastic material, by adjustment of the thickness ofthe layers in question, or by adjusting the conditions of makingpermanent line seals 14 and 15 such as by adjusting platen temperature,dwell time, or platen pressure, by using opposing heated platens, byrepeating the heat sealing operation, and the like. As mentioned above,however, it is important that the proper seal characteristics arepresent after steam sterilization.

The plastic material of web 12 in essentially impervious to steam andmust be rendered pervious such as by being perforated as at 124 in FIGS.2-3 to permit the sterilizing fluid to pass through the web. The sizeand number of perforations 124 may vary widely, the only requirementbeing to ensure adequate passage of sterilizing fluid for sterilization.It is not required that web 12 have barrier properties. It is preferredto provide relatively large perforations of about 1/4 inch in diameterover the surface of the intermediate web 12. However, the size andnumber of the perforations can vary widely. For example, perforations ofabout 0.05 mm to 1 mm in diameter spaced apart about 0.5 to 5 mm aresuitable, as are 1/4" circular perforations spaced apart about 1 to 4inches. Perforations much smaller than the width of line heat seals 14and 15 will not affect the integrity of the heat seals and may extendinto the line heat seal regions of web 12. Large perforations, however,should be confined to regions peripherally inside the line heat sealsfor seal integrity.

The weight or thickness of intermediate web 12 can vary widely, andconsiderations similar to those mentioned above are applicable to web 12although the abrasion and tear resistance are not as important as in anouter web. Thickness must of course be sufficient to retain integrityduring normal handling, but increasing thickness significantly beyondthat point will general increase costs and is therefore undesirable. Ingeneral, an overall thickness of the intermediate web is suitably from 1to 10 mils, and preferably from 2 to 7 mils (one mil=0.001 inch). Theintermediate web is usually a multi-layer web and, in that event, thethickness of each layer of the web is suitable from 10 to 80%, andpreferably 5-95%, of the web thickness.

Bottom layer 121 is heat sealed at line seal 14 to lower web 11 at alocation peripherally outside of the perforated region of web 12. In theembodiment illustrated in FIGS. 1-3, line heat seal 14 is located atmarginal regions A, B, and C adjacent to three sides of the pouchpackage.

Due to considerations of sterile technique, it is preferred thatmarginal regions A and C of the line heat seals extend near or atoutside side edges 102 and 103 of the pouch. However, it is notnecessary that the heat seal be at the outside side edge of the pouch.In fact, it is preferred for processing purposes that heat seals inregions A and C are located just inside the outer edges 102 and 103.Therefore, the terms "margin", "marginal area" and "marginal region" andthe like as used herein are intended to include regions both at the edgeof a web as well as to regions which are near to such an edge.

In a preferred embodiment as illustrated in FIG. 1, portion B of theheat seal is spaced peripherally inside end 101 of the pouch in order toprovide flange areas 111, 125 and 131, respectively, in webs 11, 12, and13, the flange areas being peripherally outside of the seal area. Theflange portions are used in opening a sealed pouch as described above.Other portions of the heat seal, such as regions A and C which extendalong sides 102 and 103 of the pouch indicated in FIG. 1, are justinside the edges of the pouch in order to facilitate processing whileminimizing the amount of web material required for a given pouch.

Heat seals 14 and 15 are permanent line heat seals designed to beretained intact during normal use of the pouch. The strength ofpermanent heat seal 14 is greater than the strength of the weaker of thetwo webs which it seals and is, as aforementioned, significantlystronger than the bond strength between heat seal layer 123 and corelayer 122 of intermediate web 12.

In a preferred embodiment, the perforated region of web 12 extends overat least a major portion of the surface area of the web and is morepreferably substantially coextensive with the surface area of web 12which forms a wall of cavity 16. However, the perforated region of web12 may be considerably smaller, the major consideration being adequateporosity to sterilizing fluid during sterilization. Since the perforatedregion of web 12 need not be coextensive with web 13, it will be readilyapparent that it is necessary only that web 11 be sized to cover andenclose the perforated region of web 12, with heat seal 14 being locatedperipherally outside of the perforated region. A structure of that typewill reduce the amount of material needed for web 11, but may complicatethe method of making the pouch.

Top layer 123 of web 12 is heat sealed at permanent line heat seal 15 toupper web 13 at a location peripherally outside of cavity 16 of thepouch. In a preferred embodiment, heat seal 15 is provided in the sameregions A, B and C as heat seal 14 and is therefore superposed directlyover and is both substantially coextensive with and in substantialregistration with heat seal 14. Heat seal 15 is a permanent seal whichhas a bond strength greater than the laminating strength between layers123 and 122 of intermediate web 12 and greater than the strength of heatseal layer 123. Thus, when upper web 13 is pulled away from webs 12 and11, layers 123 and 121 delaminate and layer 123 tears, as describedabove, in the area of seal 15.

Upper web 13 is a flexible, steam impermeable plastic web which is heatsealable to top layer 123 of intermediate web 12 and is preferablytransparent to permit viewing of objects located in cavity 16. Upper web13 has a heat sealable bottom layer 132 bonded to its top layer 133. Theterms "top" and "bottom" are again used in the sense of normal use ofthe package with layer 133 uppermost and with bottom layer 132superposed directly above cavity 16 and layer 123 of web 12 as shown inFIGS. 1-3. As in the case of web 12, bonding between layers 132 and 133is preferably effected at least substantially across the entire web asin a lamination or a coextrusion. In a preferred embodiment, web 13 is alamination. However, bonding of the layers can be effected by anadhesive or by the use of one or more tie layers, and such bonding neednot be effected over the entire surface area of the layers.

The main requirements of web 13 are that it is capable of forming withlayer 123 of web 12 a permanent line heat seal having a relative bondstrength as described above. In preferred embodiments of the invention,More importantly, these relative bond or seal strengths are retainedafter high temperature vacuum cycle steam sterilization with a threeminute steam exposure phase at a temperature of at least about 270° F.

Layer 133 adds strength to upper web 13. Suitable plastics includenylon, including cast nylon which is preferred for high temperaturesteam sterilization, biaxially oriented nylon (which becomes verydistorted under high temperature steam sterilizing), and polyester, suchas polyethylene terephthalate. Heat seal layer 132 of upper web 13 ispreferably polypropylene or a propylene copolymer such as an ethylenecopolymer, or blends of such copolymers with polypropylene as describedabove. The thickness of top layer 133 is chosen to impart sufficientstrength and toughness to web 13 to permit handling of a sealed pouchcontaining a relatively heavy loaded tray as mentioned above. Ingeneral, a thickness of at about 0.3 to 8 mil is suitable and about 0.5to 6 mil is preferred. Since an increase in thickness will result inless flexibility and increased cost, thickness is preferably kept to theminimum required for sufficient strength and toughness. The thickness ofheat seal layer 132 of upper web 13 is suitably 0.5 to 6 mil andpreferably 2 to 4 mil.

The seal width of a pouch in accordance with the invention may varyconsiderably, but is preferably from 1/8" to 1", more preferably from1/8" to 3/4", and optimally approximately 1/4". The width of the sealmay be, but need not be, substantially the same throughout its length.For example, it may be desirable to have a wider or narrower seal inchevron region B than in regions A and C.

After sterilization, the package is preferably opened manually bygrasping with one hand flange area 131 of upper web 13 and graspingflange areas 111 and 125 of webs 11 and 12 simultaneously with the otherhand, and then pulling apart. Drapeability, which imbues a web with theability to fall away as it is peeled away, is an important attribute,and preferred webs of the present invention have a high degree ofdrapeability. Grasping the flanges is facilitated by providing a cut-outarea 134 in upper web 13 or by providing a similar cut out in webs 11and 12. For a rectangular type of pouch as shown in FIG. 1, it ispreferred to provide region B as a conventional chevron at one of thenarrower ends of the pouch, the angle included at the apex of thechevron preferably being from 110 to 150°, and more preferably from 130to 150°.

The delamination failure peel seal preferably extends alongsubstantially the full length line of permanent line heat seal 15.However, it is only required that the peel seal extends a distance alongthe line heat seal such that when the peel seal portion of the heat sealis fully peeled open, the contents of cavity 16 are readily accessible.For example, it is often desirable to make permanent seals between webs12 and 13 in the regions of line heat seal A and C which are at the endof the pouch and adjacent to the access opening of the pouch. Apermanent seal at this point will prevent undesirable premature peelingapart of webs 12 and 13 when an object is inserted into the pouch.

Line heat seal 15 defines the outer limits of cavity 16 for holding oneor more items to be sterilized. Line heat seal 15 does not, however,extend completely around cavity 16 as it is necessary to provide thepouch with an access opening to permit insertion into cavity 16 of anobject to be sterilized. Heat seal 15 is therefore omitted from at leastone marginal region of the pouch to provide access between webs 12 and13 into cavity 16. Preferably, a single access opening in seal 15 isprovided. In the case of a rectilinear package such as shown in FIG. 1,the access opening is preferably provided at an end 104 of the pouchremote from end 101 which is first employed in opening the sealed pouch.In the preferred embodiment shown in FIGS. 1-7, the access openingextends fully across end 104 between seal regions A and C. However, theaccess opening can be extended for a lesser distance and, as mentionedabove, it is not required that the peelable heat seals extend fully toend 104 in regions A and C.

In a preferred embodiment, line heat seal 14 is also omitted in theregion where the access opening is provided. Thus, in the pouchillustrated in FIGS. 1-7, line heat seal 14 is provided directly belowline heat seal 15 in regions A, B and C, but line heat seals 14 and 15are both omitted from end 104 of the pouch. On the other hand, it isadvantageous that webs 11 and 12 are bonded together at ends 101 and 104to facilitate handling, both when inserting an object into cavity 16 andwhen peeling apart web 13 from webs 11 and 12.

The pouch is preferably rectilinear in plan view and is more preferablyrectangular as illustrated. However, it will be readily understood thatthe pouch package can be square, oval, round, and of virtually anydesired shape.

The pouch has particular utility in high temperature vacuum cycle steamsterilization in a hospital or other facility, of trays loaded with oneor more re-useable metal instruments and the like. The trays as well asthe instruments are usually metal and are quite heavy. The trays aretypically made of stainless steel, are rectangular, having a length of 7to 21 inches, a width of 3 to 13 inches, a height of 2 to 4 inches, anda weight, when loaded, of from 5 to 16 or even up to 30 pounds. For usewith such trays, a pouch in accordance with the present invention has alength of about 20 to 36 inches, and a width of 10 to 20 inches. Suchtrays are commonly steam-sterilized at the current time only after acareful and time-consuming wrapping procedure and it is also necessaryto carry out a careful unwrapping procedure before the sterilizedinstruments can be used. As mentioned above, sterile technique must bemaintained. Trays wrapped and unwrapped in this manner can besuccessfully sterilized under high temperature vacuum cycle steamautoclave conditions at about 270° F., but the procedure istime-consuming and exacting. The present pouch avoids the conventionalwrapping and unwrapping procedure in that one simply inserts loadedtrays into cavity 16, seals the pouch, and inserts the sealed pouch in asteam autoclave for sterilization with saturated steam for theprescribed time. Preferred pouches in accordance with the invention aresterilizable with steam under high temperature steam sterilizingconditions. If desired, the pouch can be provided with a conventionalindicator means for showing that sterilization is complete. Suitableindicators include inks and tapes. After sterilization is complete, thesterilized pouch package may be stored until ready for use. Shelf lifeof a sterilized pouch package is comparable to that of the conventionalwrapped trays, and is at least about 30 days. When ready for use, thesterilized pouch package is simply opened manually by grasping theflange areas to open the delamination failure peel seal as describedabove. The two webs which surround cavity 16 have smooth plasticsurfaces which, together with the reliable peeling open of the peelseal, virtually eliminate the generation of fiber fragments or dust.Thus, the present invention provides an alternative to the conventionalCSR wrap method of steam sterilization of large heavy objects.

While the present package has particular application in thesterilization of several objects carried in a tray, the package is quiteuseful for sterilizing much lighter loads, such as a single instrument.In that event, the package may be lighter in weight and smaller in size.Suitable size includes 6-10×10-20. For these lighter loads, a singlebarrier web is usually sufficient.

After an object to be sterilized has been inserted into cavity 16, thepackage is sealed. It is, of course, required to seal the opening, ifpresent, at package end 104 between webs 11 and 12 as well as the accessopening between webs 12 and 13. This can be accomplished in any ofseveral ways, such as by providing the package with an adhesive coatingor tape or by heat sealing. The pouch illustrated in FIG. 1, forexample, is readily heat sealed in marginal region D. Heat sealing canbe readily effected by the user by employing conventional and simpleheat sealing equipment. Sealing in that event would preferably beconducted to simultaneously provide a permanent line heat seal in regionD between webs 12 and 13 and between webs 12 and 11.

In a preferred embodiment, the pouch is sealed by an adhesive stripprovided on the pouch as illustrated in pouch 10' in FIGS. 8-11. Pouch10' is the same as pouch 10 of FIGS. 1-3 except that in FIGS. 1-3, webs11, 12 and 13 are of the same length whereas in FIGS. 8-11, webs 11',12' and 13' are of progressively decreasing length. At end 101 of thepouch, the ends of webs 11', 12; and 13' are in registration. At theopposite end of the pouch, intermediate web 12' extends outwardly beyondthe end of upper web 13' forming a first flap region 127 in web 12', andlower web 11' extends outwardly beyond the end of intermediate web 12'forming a second flap portion 112' in web 11'. With the webs inregistration as shown in FIGS. 8 and 9, a length of double sidedadhesive tape 105 is applied across the full width of the pouch inposition to seal the outer edge of flap portion 127 of intermediate web12 to the upper surface of flap portion 112' of lower web 11'. In thisembodiment permanent line heat seal 14 in areas A and C preferablyextends in regions 151 beyond the outer end of upper web 11' to theouter end of intermediate web 12'.

Adhesive stock for adhesive strip 105 is widely available and preferablyincludes a removable release strip 108. The adhesive strip preferablycovers substantially all of flap portion 112' of lower web 11' and about30 to 60% of flap portion 127 of intermediate web 12'. A fold line 106is preferably provided across flap 127 at a point located between edge104' of upper web 11' and the inner edge 107 of adhesive strip 105. Toseal the access opening of cavity 16 between the top and intermediatewebs, the pouch is folded at fold line 106 to bring the outer end of theadhesive strip and lower web 14' up over the upper surface of upper web13' into the position shown in FIG. 8. The adhesive strip is presseddownwardly and adhered to the upper surfaces of the top and intermediatewebs thus sealing the access opening of cavity 16. It is preferred toseal the pouch in the manner depicted in FIGS. 8-11 and in that eventthe adhesive strip is preferably provided on the pouch as shown in FIGS.8-10 during the manufacturing process. However, it will be understoodthat there are several ways in which the pouch may be sealed.

As mentioned above, the invention has particular utility in the hightemperature vacuum cycle steam-sterilization of objects carried in traysweighing, when loaded, up to 30 pounds or more. Such trays are usuallyfabricated of stainless steel, typically 10"×20"×3", with the bottom ofthe tray being a screen positioned about 1/2-3/4 inches above the bottomof the tray sides to maintain the tray bottom, i.e., the screen, above ahorizontal surface on which the tray is placed.

While a chevron style pouch package is preferred in many instances,other arrangements of the permanent line heat seals in region B are alsouseful and may be preferred in some instances. For example, region B ofthe line heat seal may be arcuate or rectilinear. For large packages,there is a tendency for the user to peel apart from a corner of thepackage rather than from the center. For such large pouches, it ispreferred to provide a line heat seal in region B having a "barn roof"configuration such as illustrated in FIG. 14, having a generally flatcentral region B₁ and sloped regions B₂, B₃ at either side of the flatregion extending outwardly and downwardly toward the edges of thepackage, preferably at a relatively sharp angle of from 35-55°, and morepreferably about 45°, with each sloped region occupying about 20-40% ofthe length of the line heat seal in region B. When region B is of thechevron type, the sloping sides of the chevron are preferably inclineddownwardly and outwardly at an angle of 15-35°, more preferably 15-25°.It will also be apparent that it is not necessary to restrict theinitial opening of the package of region B, as such initial opening canbe effected at either of side regions A or C. In that event, it isrequired to provide enough web material outside the line heat seal topermit the respective webs to be grasped.

Apparatus for facilitating the loading of a tray into a pouch inaccordance with the invention is illustrated in FIGS. 12 and 13. Trayloading apparatus 20 includes an elongate cantilever table element 201having a substantially flat planar upper surface 202 which is intendedto be oriented such that surface 202 is oriented substantiallyhorizontally for supporting an item, such as a loaded tray, to beinserted into a sterilization pouch. The apparatus also includes acantilever support, such as U-shaped support member 203 for supportingtable 201 in horizontal position. Support member 203 may include a clampor the like (not shown) for securing the apparatus to the surface of atable or the like or for otherwise securely mounting the apparatus infixed position. Surface 202 is preferably wider than the width of a trayto be inserted into the pouch. Table 201 includes an indicator 204 forindicating the position of a tray on surface 202 of the table. Indicator204 is preferably a stop positioned to be abutted by the end of a tray205 placed on the table. Stop 204 is preferably releasably secured totable 201 such that its position along the length of table 201 isadjustable in the direction of arrow 206 in order to accommodate traysof different size. In use, tray 205, bearing one or more items to besterilized, is placed on surface 202 of table 201 with one of its endsabutting stop 204. Conventional trays of this type normally are providedwith a handle 207 at each end to facilitate handling.

A sterilizable pouch of proper size for the object to be sterilized isthen positioned to the right of loading device 20 with its accessopening facing to the left, direction being in the sense of FIGS. 12 and13. The top and intermediate webs forming the access opening to cavity16 are separated, and the tubular pouch with its closed end to the rightand with its open end to the left is moved to the left such that it ismoved over and envelops table 201 and tray 205, thus positioning tray205 in cavity 16 of the pouch, direction again being in the sense ofFIGS. 12 and 13. Stop 204 is positioned on table 201 such that thetubular pouch is free to move (to the left is sense of FIGS. 12 and 13)sufficiently far beyond the object to be sterilized to enable the openend of the tubular pouch to be later sealed such that the object to besterilized is reliably sealed within cavity 16. It will be apparent thatindicator 204 need not be a stop and that various indicators may beemployed. For example, table 201 could be provided with indicator marksfor showing the proper positioning of trays of different size.

The pouch and trays are then removed together from table 201 to enablethe pouch to be sealed. Since the pouch is flexible, removal can beeffected manually by grasping the object despite the overlying web ofthe pouch. For example, handles at the end of a tray can be easilygrasped through the overlying web of the pouch in this manner. Afterbeing removed from table 201, the pouch and tray are placed on asubstantially horizontal surface and the pouch is then sealed asdescribed above. The sealed pouch is then ready for sterilization.

Table 201 may be provided with a roller 208 mounted at its distal end tofacilitate placement and removal of a heavy tray on the table. For thispurpose, roller 208 is mounted such that its uppermost roller surfaceextends slightly above, in the sense of FIGS. 12 and 13, the plane ofsurface 202.

Sterilization is then carried out in conventional high temperaturevacuum cycle steam sterilizing equipment in which steam sterilization iseffected at a temperature of at least about 270° F. with at least athree minute steam exposure phase. Preferred sterilizable pouches inaccordance with the present invention withstand such sterilizationconditions without impairment of the integrity of the heat seals or ofthe peelability of the delamination failure seal. In fact, peelabilityof the delamination failure peel seal is enabled by sterilization atelevated temperature as mentioned above.

After steam sterilization, the pouch and object are removed from theautoclave and may be stored at ambient conditions to await use. Becausethe pouch webs are flexible, moving a pouch loaded with a heavy tray inand out of an autoclave is facilitated because the tray itself can begrasped through the pouch when the tray is completely sealed within thepouch. Shelf life of the sterilized pouch is comparable to that of aconventional wrapped tray and is at least 30 days.

Pouches in accordance with the invention are preferably made onpouch-forming machines which are of conventional design and which may befully automated. It is preferred to form the line heat sealssimultaneously in one or more heating steps. It is also preferred thatthe line heat seals 14 and 15 are superposed directly over one anotheras shown in the drawings. In that event, it is preferred to use twoopposed heated platens to effect the line heat seals, one heated platenbearing against web 11 and the other heated platen bearing against web13. It will be readily apparent, however, that the seals may be formedseparately. For example, two webs may be heat sealed before the thirdweb is added and heat sealed.

The invention is illustrated in the example which follows.

EXAMPLE 1

A plurality of pouch packages of the general type indicated in FIGS.8-11 are fabricated by heat sealing three webs along a line heat seal inregions A, B and C. In each package, lower web 11' is "Securon",commercially available from the Fiberweb Group. The web is a drapablenon-woven barrier fabric having a trilaminate structure with spunbondedpolypropylene outer layers and an inner layer of melt blownpolypropylene fibers, with a weight of 1.8 ounces per square yard. Web11' is 163/4 inches in width and 303/4 inches in length. Intermediateweb 12' is a three layer coextrusion having a bottom heat seal layer 121for forming a permanent line heat seal 14 with the non-woven barrierfabric web, a top heat seal layer 123 for forming a permanent line heatseal 15 with upper web 13', and a core layer 122 bonded to heat seallayers 121 and 123 and which delaminates from upper heat seal layer 123in the area of permanent line heat seal 15 when the heat-sealed packageis peeled open. Bottom heat seal layer 121 is a blend of 50% by weightpolypropylene (PPE) and 50 wt % polyisobutylene-modified (orrubber-modified) high density polyethylene (RMHDPE). Core layer 122 is ablend of blend 20% by weight of polypropylene and 80% by weight ofRMHDPE (Paxon 3204), containing about 35% by weight of polyisobutylene.Upper heat seal layer 123 is PPE. Intermediate web 12' is provided witha grid pattern of perforations, each perforation being a circle having adiameter of 1/4 inch, with the circles spaced about 2 inches lengthwiseof the pouch and about 31/2 inches across the width of the package. Inthe example, there are a total of 65 of the perforations. Web 11'extends outwardly about 1/2 inch beyond the end of intermediate web 12'forming flap portion 112' in web 11' as shown in FIG. 8. Webs 11' and12' are in registry along their other three sides. Upper web 13' is atransparent tough adhesive lamination having a polypropylene heat seallayer 132 for forming a permanent line heat seal with heat seal layer123 of intermediate web 12'. Layer 133 is 0.75 mil cast nylon. Layers132 and 133 are adhesively bonded. Web 13' is shorter than webs 11' and12' by about 1" at the chevron end of the package to facilitate peelingopen of the sealed package and by about 11/2 inches at the other end toform flap portion 127 in web 12'. The side edges of all three webs arein registry.

Permanent line heat seals 14 and 15 are then made in regions A, B and Cusing opposed heated platens for about 1 second at a pressure of about300 psi with the upper platen at a temperature of about 330° F., andwith the lower platen at a temperature of about 200°. Additional heatseals (not shown in the drawings) are also made between webs 11' and 12'at their outer ends so that the outer ends can be handled as a singleweb, thus facilitating insertion of an object before sterilization andopening of the pouch after sterilization. After formation of thepermanent line heat seal, an acrylic cohesive substrate layer 105("Anchorbond 593") with release layer 108 is applied as shown in FIG.10.

A stainless steel tray loaded with stainless steel medical instrumentsto be sterilized is then inserted into cavity 16 of the pouch throughthe access opening between webs 12' and 13', that is, through the openend of the pouch not having permanent line heat seals 14 and 15. Theopen end is then sealed as described above in connection with FIGS.8-11. The sealed pouch is then autoclaved in a conventional hightemperature automated vacuum cycle steam autoclave having an exposurephase of 3 minutes exposure to saturated steam for 3 minutes. Afterstorage for 30 days at room temperature and at ambient relativehumidity, the tray and instruments remain sterile.

After storage for 30 days, the packages are reliably and predictablyopened as described in connection with FIGS. 4-6 virtually no occurrenceof fracturing of the top web.

EXAMPLE 2

A plurality of packages are fabricated in the same manner as in Example1 except that two of the Securon webs are employed as bottom webs 11,11' as illustrated in FIG. 3A. Results are substantially the same asreported in connection with the packages of Example 1.

What is claimed is:
 1. A flexible, high temperature steam-sterilizablepouch package comprising:a flexible, steam-permeable non-woven lowerbarrier web; a flexible impermeable plastic upper web; and a flexible,plastic intermediate web having an interior steam-permeable region; saidintermediate web being bonded to said upper web by a permanent line heatseal located peripherally outside said steam-permeable region, saidpermanent line heat seal defining limits of a cavity between said upperweb and said intermediate web for receiving an object to be sterilized,said permanent line heat seal extending less than fully peripherallyaround said permeable region whereby a heat seal-free region of saidpermanent line heat seal provides an access opening for inserting anitem to be sterilized into said cavity; said intermediate web beingbonded to said barrier web such that, when the pouch is fully sealed,steam can penetrate into said cavity only by passing first through saidbarrier web and thereafter through said permeable region of saidintermediate web; one of said intermediate and upper webs being amulti-layer web having a first heat sealable layer and a core layerbonded thereto, and the other of said intermediate and upper webs beingheat sealed to the heat sealable layer of said multi-layer web by saidpermanent line heat seal; after high temperature steam sterilization ofthe package, the bond strength of said permanent line heat seal beingstronger than the bond strength between said first heat sealable layerand said core layer of said multi-layer web, and the bond strengthbetween said first heat sealable layer and said core layer of saidmulti-layer web being greater than the strength of said first heatsealable layer of said multi-layer web, whereby after such hightemperature steam sterilization, a delamination failure peel seal ispresent between said intermediate and upper webs in the region of atleast a portion of said permanent line heat seal.
 2. A flexible,steam-sterilizable pouch package according to claim 1 wherein saidintermediate web is said multi-layer web and wherein said upper web issaid other web.
 3. A flexible, steam-sterilizable pouch packageaccording to claim 2 wherein said upper web is transparent.
 4. Aflexible, steam-sterilizable pouch package according to claim 3 whereinsaid upper web comprises a layer of a strong plastic and a heat sealablelayer bonded thereto, said heat sealable layer of said upper web beingbonded to said first heat sealable layer of said multi-layer web by saidpermanent line heat seal.
 5. A flexible, steam-sterilizable pouchpackage according to claim 4 wherein said multi-layer web comprises afurther heat sealable layer bonded to said core layer, said further heatseal layer being bonded to the heat sealable layer of said barrier web.6. A flexible, steam-sterilizable pouch package according to claim 1wherein said steam- permeable barrier web comprises a plurality ofnon-woven layers.
 7. A flexible, steam-sterilizable pouch packageaccording to claim 1 further comprising an adhesive layer for sealingsaid access opening.
 8. A method of high temperature steam-sterilizationof an object which comprises:(a) providing a flexible high temperaturesteam-sterilizable pouch comprising:a flexible, steam-permeablenon-woven lower barrier web; a flexible impermeable plastic upper web;and a flexible, plastic intermediate web having an interiorsteam-permeable region; said intermediate web being bonded to said upperweb by a permanent line heat seal located peripherally outside saidsteam-permeable region, said permanent line heat seal defining limits ofa cavity between said upper web and said intermediate web for receivingan object to be sterilized, said permanent line heat seal extending lessthan fully peripherally around said permeable region whereby a heatseal-free region of said permanent line heat seal provides an accessopening for inserting an item to be sterilized into said cavity; saidintermediate web being bonded to said barrier web such that, when thepouch is fully sealed, steam can penetrate into said cavity only bypassing first through said barrier web and thereafter through saidpermeable region of said intermediate web; one of said intermediate andupper webs being a multi-layer web having a first heat sealable layerand a core layer bonded thereto, and the other of said intermediate andupper webs being heat sealed to the heat sealable layer of saidmulti-layer web by said permanent line heat seal; (b) placing an objectto be sterilized in the cavity of the pouch; (c) sealing the pouch suchthat the object to be sterilized is sealed in said cavity and such thatsteam can penetrate into said cavity only by first passing through thelower web and then through the perforated region of the intermediateweb; and (d) steam sterilizing the sealed pouch at a temperature of atleast 270° F., whereby after sterilizing in step (d), the bond strengthof said permanent line heat seal being stronger than the bond strengthbetween said first heat sealable layer and said core layer of saidmulti-layer web, and the bond strength between said first heat sealablelayer and said core layer of said multi-layer web being greater than thestrength of said first heat sealable layer of said multi-layer web, anda delamination failure peel seal is present between said intermediateand upper webs in the region of said permanent line heat seal.
 9. Amethod according to claim 8 wherein steam sterilizing comprises exposingthe sealed pouch to saturated steam at a temperature of at least 270° F.for at least 3 minutes.